Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:20 AM
Study NCT ID:
NCT07448961
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-04
First Post:
2026-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
INDIVIDUALIZED DUAL-TASK TRAINING FOR BALANCE AND MOBILITY IN OLDER ADULTS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The study is a single-blind trial. While participants and the physical therapist providing the intervention cannot be blinded to the group assignments due to the nature of the exercises, the outcome assessor who performs all baseline and post-intervention measurements will be kept blinded to the group allocations. Data analysis will also be conducted by a researcher blinded to the group codes.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a prospective, randomized, single-blind, parallel-group clinical trial. Participants are randomly assigned to one of three groups (individualized dual-task training, standardized dual-task training, or single-task control) in a 1:1:1 ratio. The primary objective is to compare the effects of individualized versus standardized protocols over an 8-week intervention period.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-26', 'studyFirstSubmitDate': '2026-02-26', 'studyFirstSubmitQcDate': '2026-02-26', 'lastUpdatePostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dual-Task Cost (DTC) of Functional Mobility', 'timeFrame': 'Baseline and at the end of the 8-week intervention.', 'description': 'Dual-Task Cost (DTC) will be calculated based on the Timed Up and Go (TUG) test performance. DTC represents the percentage change in TUG time during a cognitive-motor dual-task condition (e.g., walking while counting backwards) compared to a single-task condition (walking only). The formula is: DTC = \\[(Dual-Task Time - Single-Task Time) / Single-Task Time\\] X 100. A higher percentage indicates greater interference and poorer dual-task performance.'}], 'secondaryOutcomes': [{'measure': 'Berg Balance Scale (BBS)', 'timeFrame': 'Baseline and at the end of the 8-week intervention.', 'description': 'A 14-item objective measure used to assess static balance and fall risk in adult populations. Each item is scored on a 5-point scale ranging from 0 to 4. Total scores range from 0 to 56, where higher scores indicate better balance and functional mobility.'}, {'measure': '10-Meter Walk Test (10MWT)', 'timeFrame': 'Baseline and at the end of the 8-week intervention.', 'description': 'Used to assess walking speed in meters per second (m/s) over a 10-meter distance. Faster times (higher m/s) indicate better functional mobility and gait performance.'}, {'measure': 'Falls Efficacy Scale-International (FES-I)', 'timeFrame': 'Baseline and at the end of the 8-week intervention.', 'description': 'A 16-item self-report questionnaire used to assess the level of concern about falling during social and physical activities. Scores range from 16 to 64. Higher scores indicate a greater fear of falling.'}, {'measure': 'Montreal Cognitive Assessment (MoCA)', 'timeFrame': 'Baseline and at the end of the 8-week intervention.', 'description': 'A brief screening tool used to assess general cognitive functions, including executive functions, memory, and attention. Total scores range from 0 to 30. Higher scores indicate better cognitive function.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Older Adults', 'Postural Balance', 'Dual Task Exercises in Elderly People', 'Dual Task Cost']}, 'referencesModule': {'references': [{'pmid': '35940246', 'type': 'RESULT', 'citation': 'Pike A, McGuckian TB, Steenbergen B, Cole MH, Wilson PH. How Reliable and Valid are Dual-Task Cost Metrics? A Meta-analysis of Locomotor-Cognitive Dual-Task Paradigms. Arch Phys Med Rehabil. 2023 Feb;104(2):302-314. doi: 10.1016/j.apmr.2022.07.014. Epub 2022 Aug 6.'}, {'pmid': '41566097', 'type': 'RESULT', 'citation': 'Zhang W, Zhang W, Zu G, Yao M, Li J, Jin Y, Wang L, Tang J. Effects of task-oriented training on balance, gait, and fall in older adults: A systematic review and meta-analysis of randomized controlled trials. Aging Clin Exp Res. 2026 Jan 21;38(1):56. doi: 10.1007/s40520-025-03303-1.'}, {'pmid': '41152559', 'type': 'RESULT', 'citation': 'Khan MJ, Fong KNK, Wong TW, Tsang WW, Chen C, Chan WC, Winser SJ. Effectiveness of dual-task exercise in improving balance and preventing falls among older adults: systematic review with meta-analysis and meta-regression. Eur Geriatr Med. 2025 Dec;16(6):2047-2083. doi: 10.1007/s41999-025-01328-3. Epub 2025 Oct 28.'}, {'pmid': '38364709', 'type': 'RESULT', 'citation': 'Ercan Yildiz S, Fidan O, Gulsen C, Colak E, Genc GA. Effect of dual-task training on balance in older adults: A systematic review and meta-analysis. Arch Gerontol Geriatr. 2024 Jun;121:105368. doi: 10.1016/j.archger.2024.105368. Epub 2024 Feb 9.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to prevent functional decline and improve mobility in healthy older adults aged 65 and over. The main questions it aims to answer are:\n\nWhat is the effect of individualized dual-task training on functional balance and mobility compared to standard training? Does personalized sensory and cognitive training significantly reduce the dual-task cost during walking tasks? Researchers will compare the Individualized Dual-Task Group to a Standardized Dual-Task Group and a Single-Task Control Group to see if personalized adjustments in sensory and cognitive loads lead to superior improvements in balance, gait speed, and motor-cognitive interference.\n\nParticipants will:\n\nComplete an initial assessment of motor and cognitive capacities to determine individual baseline levels.\n\nParticipate in a supervised exercise program 3 days a week for 8 weeks, with each session lasting 40-45 minutes.\n\nPerform motor tasks such as walking, obstacle crossing, and balance exercises while simultaneously engaging in cognitive tasks (e.g., counting, verbal fluency).\n\n(For the individualized group) Undergo weekly adjustments in exercise difficulty, including sensory manipulations like surface changes and head movements based on their performance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged 65 years and older.\n* Living independently in the community.\n* Ability to walk at least 10 meters without the use of an assistive device (e.g., cane, walker).\n* Cognitively intact, defined as a Montreal Cognitive Assessment (MoCA) score of 24 or higher.\n* Stable medical condition allowing for participation in an 8-week exercise program.\n* Willingness to participate in the study and provide written informed consent.\n\nExclusion Criteria:\n\n* History of neurological disorders affecting movement or cognition (e.g., Stroke, Parkinson's Disease, Dementia).\n* Acute or chronic orthopedic conditions that severely limit gait or balance (e.g., recent lower limb fracture or major joint replacement within the last 6 months).\n* Severe visual or hearing impairment that prevents following instructions or performing tasks.\n* Uncontrolled cardiovascular or pulmonary disease.\n* Currently participating in another structured exercise or dual-task training program.\n* Inability to commit to the 8-week training schedule."}, 'identificationModule': {'nctId': 'NCT07448961', 'briefTitle': 'INDIVIDUALIZED DUAL-TASK TRAINING FOR BALANCE AND MOBILITY IN OLDER ADULTS', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University - Cerrahpasa'}, 'officialTitle': 'EFFECTS OF SENSORİAL AND COGNİTİVE INDİVİDUALİZED DUAL-TASK TRAİNİNG ON FUNCTİONAL BALANCE, MOBİLİTY, AND DUAL-TASK PERFORMANCE İN OLDER ADULTS: A RANDOMİZED CONTROLLED TRİAL', 'orgStudyIdInfo': {'id': 'ebrrwlMU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Individualized Dual-Task Group', 'description': 'Participants will receive individualized cognitive-motor dual-task training 3 days a week for 8 weeks. Exercises are adjusted weekly based on individual performance levels.', 'interventionNames': ['Behavioral: Individualized Dual-Task Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standardized Dual-Task Group', 'description': 'Participants will receive a standard (fixed-progression) dual-task training program 3 days a week for 8 weeks.', 'interventionNames': ['Behavioral: Standardized Dual-Task Training']}, {'type': 'OTHER', 'label': 'Single-Task Control Group', 'description': 'Participants will perform single motor tasks (walking or balance exercises only) without simultaneous cognitive tasks for the same duration.', 'interventionNames': ['Behavioral: Single-Task Motor Training']}], 'interventions': [{'name': 'Individualized Dual-Task Training', 'type': 'BEHAVIORAL', 'description': "An 8-week, supervised exercise program (3 sessions/week, 40-45 min). Training involves simultaneous motor (walking, balance, obstacle crossing) and cognitive tasks (counting, verbal fluency). The cognitive and sensory loads are adjusted weekly based on the participant's performance (Borg Scale and task accuracy) to maintain an optimal challenge level.", 'armGroupLabels': ['Individualized Dual-Task Group']}, {'name': 'Standardized Dual-Task Training', 'type': 'BEHAVIORAL', 'description': 'An 8-week, supervised dual-task exercise program (3 sessions/week, 40-45 min). Participants perform the same motor and cognitive tasks as the individualized group, but the progression of difficulty is fixed and follows a pre-determined schedule regardless of individual performance changes.', 'armGroupLabels': ['Standardized Dual-Task Group']}, {'name': 'Single-Task Motor Training', 'type': 'BEHAVIORAL', 'description': 'An 8-week program (3 sessions/week, 40-45 min) consisting only of motor exercises such as walking and balance tasks. No simultaneous cognitive tasks or sensory manipulations are provided during the training sessions.', 'armGroupLabels': ['Single-Task Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34500', 'city': 'Istanbul', 'state': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University-Cerrahpasa, Faculty of Health Sciences', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Sezen Karabörklü Argut, PhD', 'role': 'CONTACT', 'email': 's.karaborkluargut@iuc.edu.tr', 'phone': '+902128663700', 'phoneExt': '28325'}, {'name': 'Melike N Can, PT', 'role': 'CONTACT', 'email': 'melikenur.can@ogr.iuc.edu.tr'}], 'overallOfficials': [{'name': 'Sezen Karabörklü Argut, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istanbul University-Cerrahpasa, Faculty of Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be made available to other researchers at this time to protect participant privacy and maintain data confidentiality according to the initial ethical approval.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sezen Karaborklu Argut', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Sezen Karaborklu Argut', 'investigatorAffiliation': 'Istanbul University - Cerrahpasa'}}}}